Filter and occluder systems and associated methods and devices

ABSTRACT

Various aspects of the instant disclosure relate to flow devices including filters and occluders for modifying flow in body conduits such as blood vessels. In some examples, such devices include a support structure and a flow media coupled to the support structure. The medical device generally further includes one or more capture features. In some examples, the capture features are coupled to the support structure at one or more of the proximal and distal ends of the support structure. In various examples, the capture features facilitate retrograde and antegrade deployment of the medical device and retrograde and antegrade capture of the medical device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application62/334,767, filed May 11, 2016, and also claims the benefit of U.S.Provisional application 62/448,583, filed Jan. 20, 2017, both of whichare herein incorporated by reference in their entireties for allpurposes.

SUMMARY

Various systems, methods, and devices according to the presentdisclosure are usable as flow devices, also described as filters oroccluders, such terms being used interchangeably herein unless otherwiseindicated by device application.

Some aspects of the disclosure relate to filters that remain patent foran extended period of time in comparison to traditional filters. Suchfilters may be applicable for protecting against embolic release duringcomplex endovascular procedures or other filtration applications.

Some aspects of the disclosure relate to flow devices that remain patentfor a desired period of and eventually become less patent and, ifdesired, fully or nearly fully occlusive over time. Such occluders mayfind use in a variety of applications, including techniques for reducingthe patency of one or more blood vessels, apertures ofgrafts/stent-grafts, or branches of grafts/stent-grafts over time, aswell as others.

Some aspects of the disclosure relate to flow devices that are capableof being collapsed and removed from the vasculature from either a distalor a proximal approach direction (e.g., antegrade or retrogradedirections) to facilitate, for example, intravascular removal of thedevices from different access locations.

Some aspects of the disclosure relate to flow devices that arebi-directionally deployable, where such devices can be deployed in adistal-to-proximal end or a proximal-to-distal end orientation tofacilitate, for example, intravascular deployment of the devices fromdifferent access locations.

Some aspects of the disclosure relate to flow systems including aplurality of flow devices deployed and left in place to provide suchadvantages as enhanced protection against post-operative complications,including embolisms, for example.

Some aspects of the disclosure relate to methods of making and methodsof treatment using the flow devices and systems described herein,including applications in which flow devices are implanted in the bodyfor an extended period of time (e.g., including after conclusion of aprimary treatment procedure, such as EVAR) and later retrieved from thebody after a desired time period.

While multiple examples are disclosed, still other examples will becomeapparent to those skilled in the art from the following detaileddescription, which shows and describes illustrative examples.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a retrieval system and associated flow device,according to some examples.

FIG. 1A illustrates a portion of the flow device of FIG. 1, according tosome examples.

FIGS. 2A-2F illustrate flow media, according to some examples.

FIGS. 3 and 4 illustrate another flow device, according to someexamples.

FIG. 5 illustrates another flow device, according to some examples.

FIG. 5A illustrates a portion of the flow device of FIG. 5, according tosome examples.

FIGS. 6-8 illustrates additional flow devices, according to someexamples.

FIGS. 9-12 illustrate a flow device with a flow reversion deviceinserted and deployed in the flow device, according to some examples.

FIG. 13 illustrates a system of flow devices deployed in the aorticarch, according to some examples.

FIG. 14 illustrates a retrieval system and associated flow device,according to some examples.

DETAILED DESCRIPTION

Various aspects of the instant disclosure relate to flow devices, alsodescribed as filters or occluders, for modifying flow (e.g., filtering,reducing, and/or occluding flow) in body conduits, such as bloodvessels. In some examples, such devices achieve relatively low porositywhile maintaining patency for desired periods of time, includingextended periods of time following implantation and associated procedurecessation. Some examples of device applications include use for theprevention of stroke, ischemic bowel, reduced renal function, distalperipheral artery occlusion, internal iliac occlusion, inferiormesenteric occlusion, selective filtering and/or occluding of implantbranches (e.g., stent graft branches) and others that this disclosurewill make apparent, such as partial or total occlusion of the gastricarteries for the treatment of obesity.

FIG. 1 shows a flow device 10 and retrieval system according to someexamples. As shown, the flow device 10 includes a support frame 12 and aflow media 14. The device 10 is configured for implantation in one ormore body lumens and can have an outer diameter between 3 mm and 20 mm,although a variety of dimensions are contemplated.

The support frame 12, also described as a support structure, isoptionally formed of a shape memory material, such as a nickel-titaniumalloy, although a variety of materials, such as stainless steel orsuitable polymeric materials are contemplated. If desired, the supportframe 12 is formed as a cut tube (e.g., a laser cut tube) that iscollapsible to an elongated, smaller diameter profile (not shown) forintraluminal deployment using a delivery system (e.g., a deliverycatheter). If desired, the support frame 12 is optionally formed ofdiscrete wires, for example using one or more mandrel wire formingoperations. Although some examples are provided, a variety of frameshapes, materials, and manufacturing methods are contemplated, includingthose disclosed in U.S. Pat. No. 8,668,714 (Cully et al.), issued Mar.11, 2014. In some examples, the support frame 12 is configured toself-expand or to be expanded (e.g., via balloon) to engage the wall ofthe body lumen into which it is deployed (e.g., against a blood vesselwall, such as the aortic arch) to anchor the device 10 in place.

As shown in FIG. 1, the support frame 12 includes a proximal portion 20,a distal portion 22 and an intermediate portion 24 between the proximaland distal portions 20, 22. As shown, the support frame 12 is generallyformed of a plurality of frame members 30, also described as struts 30.The frame members 30 are optionally portions of a cut tube, discretewires wound or coupled together, or of another design as desired. Thesupport frame 12 is optionally self-expanding or expandable (e.g.,balloon expandable) as desired.

The proximal portion 20 includes a first capture feature 32, and tapersconically away from the intermediate portion 24. An enlarged view of thecapture feature 32 is shown in FIG. 1A.

As shown in FIG. 1A, the capture feature 32, also described as acoupling means 32, extends from the plurality of struts 30 and forms agenerally spherical shape (e.g., round spherical), although a variety ofshapes (e.g., oblong spherical) are also contemplated. In some examples,for example when formed by laser cutting, the capture feature (orcapture element) includes one or more relief cuts to facilitate formingthe capture feature 32 into a desired shape (e.g., similar to a bell, or“jingle bell”). Though largely obscured in FIG. 1A, a first radiopaquemarker 34 (e.g., a discrete piece of radiopaque material) is optionallyreceived and retained in the first capture feature 32. The firstradiopaque marker 34 is optionally used to assist with placement of thedevice 10 during a deployment operation and/or to recover the device 10during a recovery, or retrieval operation, for example.

As shown in FIG. 1, and though partially obscured by the flow media 14,the intermediate portion 24 of the support frame 12 is generallycylindrical in shape, although a variety of shapes (e.g., tapered,hourglass, dog bone, and others) are contemplated.

The distal portion 22 of the support frame 12 is shown in FIG. 1 largelycovered by the flow media 14. In some examples, the distal portion 22 ofthe support frame 12 tapers conically to a second capture feature 40. Asshown in FIG. 1, the tapered distal portion 22 supports the flow media14 in a corresponding conical shape shown in FIG. 1. The second capturefeature 40, also described as a coupling means 40, is optionallysubstantially similar to the first capture feature 32. For example, thesecond capture feature 40 can be similarly shaped and formed to thefirst capture feature 32 and also includes a second radiopaque marker42, although a variety of configurations are contemplated. If desired,the first and second capture features 32, 40 and/or the first and secondradiopaque markers 34, 42 are distinct from one another, for examplehaving different radiopacities, shapes, materials, coatings, orotherwise being distinguishable from one another.

As shown in FIG. 1, the flow media 14 includes a first portion 50received over an outside surface of the intermediate portion 24 of thesupport frame 12 and a second portion 52 received over the distalportion 22 of the support frame 12. The flow media 14 is optionallydescribed as a porous fabric, where the term “porous fabric” isgenerally meant to indicate a layer of material configured to permit atleast some level of fluid passage (having a desired fluid permeability)through one or more flow pathways or “pores” in the material.

As shown in FIG. 1, the first portion 50 is received outside of theintermediate portion 24. Though shown outside the intermediate portion24, a variety of configurations are contemplated, including the firstportion 50 being received on an inner surface of the intermediateportion 24, embedded with the intermediate portion 24, comprisingmultiple layers or parts sandwiching the intermediate portion 24, andothers. In some examples, the first portion 50 of the flow media 14 issubstantially continuous, where the first portion 50 may besubstantially impermeable or permeable, or have any desired permeabilityto gases or water, blood, bile, or other bodily fluids as desired. Insome examples, the first portion 50 is formed of one or more layers ofexpanded PTFE film adhered (e.g., by FEP applied to the film and/orsupport frame 12) or otherwise secured to the support frame 12 (e.g., bysuturing, friction fit, or other means for securing).

According to some examples, the second portion 52 of the flow media 14,also described as the filtration portion 52 or flow control portion 52,includes a plurality of openings such that the second, or flow controlportion 52 is permeable to fluid flow, for at least an initial desiredtime period. The flow control portion 52 is optionally configured tocapture particulate or other substances in a fluid passing through theflow control portion 52. For example, with blood, it may be desirable tocapture plaque debris, blood clot debris, or other content. As describedin greater detail below, in some examples, one or more portions of thedevice 10 (e.g., the flow control portion 52) includes drug coatings,surface treatments (e.g., such as the surface treatment marketed underthe tradename “CBAS” by W. L. Gore & Associates), or othermodification(s) to facilitate a breakdown of material caught in the flowcontrol portion 52.

In some examples, the device 10 is configured to be delivered“off-the-wire,” without riding on a guidewire captured within a lumen ofthe device. However, as discussed further below, in some examples, oneor more guidewires may be utilized during delivery of the device 10. Insome examples, the device 10 can be deployed using well knownintravascular catheter techniques from a compacted delivery profile toan expanded deployed profile. In at least this manner, the device 10 canbe left in the body following a procedure or a portion of a procedurewithout the need of removing a guidewire from the device 10 and/orremoving the device 10 with an associated treatment device, such as anassociated balloon catheter or stent-graft deployment system. Moreover,multiple devices can be deployed from a single delivery system atdifferent delivery sites using such an “off-the-wire” approach.Generally, push/pull delivery catheters, constraining sheaths, and otherdelivery systems are contemplated for deploying the devices as desired.

FIG. 1 also shows a capture system 60 including a guide catheter 62 anda snare catheter with a retractable loop 64. As indicated in FIG. 1, thecapture system 60 is optionally used to capture the first capturefeature 32 at which point the device can be withdrawn and collapsed intothe guide catheter 62 or another collapsing feature for withdrawal orposition adjustment of the device. Additionally, the capture system 60or a similar capture system is optionally utilized to capture andretrieve the device 10 using the second capture feature 40. In otherwords, the device 10 configuration facilitates retrieval and removaland/or repositioning of the device 10 from either distal or proximalapproaches, also described as ante- or retrograde approaches in terms offlow. Thus, a user of the device 10 and capture system 60 is able toapproach the device from different vascular entry points, or directionswithin a body lumen, as desired.

FIGS. 2A-2F show a variety of potential configurations for the openingsin the flow media 14, such as the flow control portion 52. Openings maybe formed by removal processes (e.g., cutting or etching) films, sheets,membranes, or other materials. Openings may also be formed by weaving,knitting, or other techniques using individual or multi-fiber strands,or using other materials and/or methods as desired.

FIG. 2A shows a square lattice structure, such as those described inU.S. Pub. US 2013/0204347 (“Armstrong et al”), published Aug. 8, 2013usable for the flow media 14. FIG. 2B shows a modified lattice structurein which the openings are offset and rectangular, according to someexamples of one or more portions of the flow media 14 (e.g., flowcontrol portion 52). FIG. 2C shows a series of slits with a desiredlength, depth, and separation; FIG. 2D shows a series of ovular, oroval-shaped openings of a desired length, width, number and separation;FIG. 2E shows generally round openings with a desired diameter andseparation; and FIG. 2F shows a series of random, irregular openingsformed by an irregular fibrous structure; each of the foregoing providejust a few examples of configurations of one or more portions of theflow media 14 (e.g., configurations of the flow control portion 52).

The openings generally define a porosity level of the flow media 14. Forexample, in some examples, the porosity level is defined as an averageor maximum diameter or dimension of the openings being 500 microns, 400microns, 300 microns, 200 microns, 100 microns, or other dimension. Insome implementations (e.g., where occlusion is desirable), the porositylevel is defined as an average or a maximum diameter or dimension of theopenings being less than 100 microns, such as 50 microns, 10 microns, or5 microns, for example. The porosity level can also be defined as theopenings being configured to filter down to 500 micron, 400 micron, 300micron, 200 micron, or 100 micron or other maximum or average particlesize. In some implementations, (e.g., where occlusion is desirable), theporosity level of the flow media 14 is defined as the openings beingconfigured to filter down to a maximum or average particle size of lessthan 100 micron particles sizes, such as 50 micron, 10 micron, or 5micron particle sizes, for example.

In some examples, the flow control portion 52 is configured to remain ata desired patency level for a desired time period (e.g., minutes, hours,days, weeks, or months). In some examples, this facilitates use of thedevice 10 to remain implanted following completion of the primaryprocedure (e.g., EVAR) and to reduce the incidence of postoperativecomplications (e.g., stroke from embolic debris) by remaining in thebody following completion of the procedure for a desired period (e.g.,maintaining a desired patency for a period of between 12 hours and a 7days). In some examples, this extended patency helps allow controlledocclusion of vessel and/or portion of an endovascular device (e.g.,stent graft) to reduce issues (e.g., system circulatory issues)associated with immediate or near immediate occlusion of such pathways.For example, a more gradual occlusion or “low flow” occlusion may permitthe body to accommodate such partially or reduced flow in the bodyvessel and thereby reduce negative physiologic impact.

The flow media 14 or a portion thereof (e.g., the flow control portion52 of the flow media 14) is optionally provided with one or moretreatments (e.g., the heparin-based treatment provided by W.L. Gore andAssociates under the trade name “CBAS”) to maintain device patency for adesired period of time. In some examples, the flow control portion 52 isformed of expanded PTFE material or other fluoropolymer, although any ofa variety of biocompatible biomaterials are contemplated. Variousadjustments can be made to the material as desired, including the numberand type of material layers (e.g., expanded PTFE microstructure,density, layer-to-layer variations) and opening configurations (size,spacing, shape, and others) in order to achieve a desired patency, orflow vs. time profile for the device 10. In some examples, the desiredpatency is defined in terms of a minimum volumetric flow rate throughthe device 10 over the desired time period. The desired patency can alsobe described in terms of a minimum percentage of the initial volumetricflow rate exhibited by the device at the time of implantation over thedesired time period (e.g., at around 100%, 90%, 80%, etc.).

FIGS. 3 and 4 show another flow device 110, according to some examples.FIG. 3 is an isometric representation and FIG. 4 is generally a side,partial sectional representation of the device 110. As shown, the device110 includes various features similar to those of the device 10. Forexample, the device 110 includes a support frame 112 and a flow media114. The support frame 112 also includes a proximal portion 120, adistal portion 122 and an intermediate portion 124 between the proximaland distal portions 120, 122. As shown, the support frame 112 isgenerally formed of a plurality of frame members 130, also described asstruts 130. The frame members 130 are optionally portions of a cut tube,discrete wires wound or coupled together, or of another design asdesired. The support frame 112 is optionally self-expanding orexpandable (e.g., balloon expandable) as desired.

The proximal portion 120 is optionally conically tapered and extends toa first capture feature 132, also described as a coupling means.

As shown in FIGS. 3 and 4, the capture feature 132 is optionallysubstantially similar to the capture features (or capture elements)previously described in association with device 10, although a varietyof designs are contemplated.

As shown in FIGS. 3 and 4, the intermediate portion 124 of the supportframe 112 is generally cylindrical in shape, although a variety ofshapes (e.g., tapered, hourglass, dog bone, and others) arecontemplated.

As shown in FIGS. 3 and 4, the distal portion 122 of the support frame112 tapers conically to a second capture feature 140. As describedbelow, the proximal and distal portions 120, 122 receive the flow media114 depending upon a position of the flow media 114 as dictated by flowdirection.

The second capture feature 140 is optionally substantially similar tothe second capture feature 40, although a variety of configurations arecontemplated.

As shown in FIGS. 3 and 4, the flow media 114 includes a first portion150 received on an inside surface of the intermediate portion 124 of thesupport frame 112. The first portion 150 is optionally substantiallycylindrical, or tubular in shape. Though shown outside the intermediateportion 124, a variety of configurations are contemplated, including thefirst portion 150 being received on an outer surface of the intermediateportion 124, embedded with the intermediate portion 124, comprisingmultiple layers sandwiching the intermediate portion 124, and others. Insome examples, the first portion 150 of the flow media 114 issubstantially continuous, with the first portion 150 being substantiallyimpermeable or permeable, or having any desired permeability to gases orwater, blood, bile, or other bodily fluids as desired. In some examples,the first portion 150 is formed of one or more layers of expanded PTFEfilm adhered (e.g., by FEP applied to the film and/or support frame 112)or otherwise secured to the support frame 112 (e.g., by suturing,friction fit, or other securing means). As shown, the first portion 150is generally cylindrical, or tubular in shape, although a variety ofshapes are contemplated.

According to some examples, the second portion 152 of the flow media 114is substantially conical in shape and is attached to the first portion150 of the flow media (e.g., generally at the middle of the firstportion, extending inwardly from the first portion 150). Similar to theflow control portion 52, the second portion 152, also referred to as thefiltration portion 152 or flow control portion 152, includes a pluralityof openings such that the flow control portion 152 is permeable to fluidflow for at least desired time period, according to some examples. Theflow control portion 152 is modifiable similarly to the flow controlportion 52 to achieve a desired patency, or flow vs. time profile forthe device 110.

With the flow control portion 152 so configured, predominant flow isable to flip the flow control portion 152, or otherwise cause itsconfiguration to mirror, in vivo. This feature, though not alwaysnecessary for such a bidirectional advantages, can provide the benefitof being able to implant the device 110 in either direction, withoutregard to whether the distal end or proximal end is pointing in thedirection of flow. This, coupled with the ability to retrieve the devicefrom either direction, provides even further benefits in the ability todeliver and/or retrieve the device 110 in antegrade or retrogradedirections, for example. In particular, where the device 110 ispre-loaded with a delivery system (not shown) the ability to deliver thedevice 110 from either direction can be particularly advantageous as auser is not required to select a retro- or antegrade approach based uponthe device orientation as assembled with the delivery system (notshown).

FIGS. 5 and 5A show still another flow device 210 according to someexamples. As shown in FIG. 5, the device includes a support frame 212and a flow media 214. The support frame 212 includes a proximal portion220, a distal portion 222 and an intermediate portion 224 between theproximal and distal portions 220, 222. As shown, the support frame 212is generally formed of a plurality of frame members 230, also describedas struts 230. The frame members 230 are optionally portions of a cuttube, discrete wires wound or coupled together, or of another design asdesired. The proximal portion 220 includes a first capture feature 232,also described as a coupling means 232, and the struts 230 at theproximal portion 220 curve inwardly to define a recurved, or invertedframework. An enlarged view of the first capture feature 232 is shown inFIG. 5A. The support frame 212 is optionally self-expanding orexpandable (e.g., balloon expandable) as desired.

As shown in FIG. 5A, the first capture feature 232 includes theplurality of struts 230 forming a generally spherical shape (e.g., roundspherical), although a variety of shapes (e.g., oblong spherical) arealso contemplated. Though largely obscured in FIG. 5A, a firstradiopaque marker 234, (e.g., a discrete piece of radiopaque material)is optionally received and retained in the first capture feature 232.The first radiopaque marker 234 is optionally used to assist withplacement of the device 210 during a deployment operation and/or torecover the device 10 during a recovery, or retrieval operation.

As shown in FIG. 5, and though largely obscured by the flow media 214,the intermediate portion 224 of the support frame 212 is generallycylindrical in shape, although a variety of shapes (e.g., tapered,hourglass, dog bone, and others) are contemplated.

The distal portion 222 of the support frame 212 is shown in FIG. 5largely covered by the flow media 214. In some examples, the distalportion 222 of the support frame 212 tapers conically to a secondcapture feature 240. As shown in FIG. 5, the tapered distal portion 222supports the flow media 214 in a corresponding conical shape shown inFIG. 5. The second capture feature 240 is optionally substantiallysimilar to the first capture feature 232, the second capture feature 240being similarly shaped and formed and also including a second radiopaquemarker 242, although a variety of configurations are contemplated. Ifdesired, the first and second capture features 232, 240 and/or the firstand second radiopaque markers 234, 242 are distinct from one another,for example having different radiopacities, shapes, materials, coatings,or otherwise being distinguishable from one another.

As shown in FIG. 5, the flow media 214 includes a first portion 250received over an outside surface of the intermediate portion 224 of thesupport frame 212 and a second portion 252. Though shown outside theintermediate portion 224, a variety of configurations are contemplated,including the first portion 250 being received on an inner surface ofthe intermediate portion 224, embedded with the intermediate portion224, comprising multiple layers sandwiching the intermediate portion224, and others. As shown in FIG. 5, the first portion 250 of the flowmedia 214 is substantially continuous and includes a scalloped edge. Thefirst portion 250 may be substantially impermeable or permeable, or haveany desired permeability to gases or water, blood, bile, or other bodilyfluids as desired. In some examples, the first portion 250 is formed ofone or more layers of expanded PTFE film adhered (e.g., by FEP appliedto the film and/or support frame 212) or otherwise secured to thesupport frame 212 (e.g., by suturing, friction fit, or using othersecuring means).

Similarly to the devices 10 and 110, according to some examples, thesecond portion 252 of the flow media 214, also described as thefiltration portion 252 or flow control portion 252, includes a pluralityof openings such that the second, or flow control portion 252 ispermeable to fluid flow for at least a desired time period. The flowcontrol portion 252 is modifiable similarly to the flow control portions52, 152 to achieve a desired patency, or flow vs. time profile for thedevice 210.

In the device 210, the capture portions 232, 240 are optionally usedsimilarly to the capture portions 32, 132, 40, 140 for bi-directionalretrievability of the device 210 following deployment in body lumen(e.g., blood vessel).

FIGS. 6, 7, and 8 show additional flow devices 310, 410, and 510respectively. As shown in FIG. 6, the flow device 310 includes a supportframe 312 and a flow media 314. The support frame 312 is optionally anexpandable or self-expanding stent structure and the flow media 314 isgenerally similar to the flow media 14, 114, 214 previously described,although as shown the flow media 314 is generally disc-shaped andextends across the inner-lumen of the support frame 312. The flow media314 includes a plurality of flow control portions 352, each positionedat a different longitudinal location along the support structure 312.

FIG. 7 shows the flow device 410 including a support frame 412 and aflow media 414. The support frame 412 is optionally an expandable orself-expanding stent structure and the flow media 414 is generallysimilar to the flow media 14, 114, 214, 314 previously described,although as shown the flow media 414 is generally conical, ordome-shaped and extends across the inner-lumen of the support frame 414.In some examples, the flow media 414 is capable of reversing or“flipping” in direction with flow, as described in association withother examples. As shown, the flow media 314 includes a single flowcontrol portion 452 positioned at a single, intermediate position,although a variety of positions are contemplated.

FIG. 8 shows the flow device 510 including a support frame 512 and aflow media 514. The support frame 512 is optionally an expandable orself-expanding stent structure and the flow media 514 is generallysimilar to the flow media 14, 114, 214, 314, 414 previously described,although as shown the flow media 514 is a fibrous material (e.g., afibrous mat or matrix) that extends across the inner-lumen of thesupport frame 512. As shown, the flow media 514 includes a single flowcontrol portion 552 positioned at a single, proximal position, althougha variety of positions are contemplated.

A variety of device designs and features have been disclosed. It shouldbe understood that any combinations of any of the features from devices10, 110, 210, 310, 410, 510 are contemplated.

FIGS. 9-10 illustrate a method of flow reversion, according to someexamples, with reference to the device 310 although similar concepts maybe applicable to one or more of the other flow devices described herein.FIG. 9 is a schematic view of the device 310 from a side view showingthe support frame 312 and flow media 314. FIG. 10 shows a ballooncatheter device 600 (e.g., a balloon catheter 610 with a deployablestent 612 received over the balloon 614 of the balloon catheter 610)pushed through the flow media 314 with the balloon 614 inflated and thesecondary stent 612 pressing the flow media 314 against the inner wallof the support frame 312. FIG. 11 shows the balloon catheter removed andFIG. 12 is an end view of the device 310 with the secondary stent 612reverted generally to the flow available prior to insertion anddeployment of the device 310.

Some examples relate to a flow system comprised of multiple, independentflow devices that can be deployed on any of the branches of the aortaduring endovascular aneurysm repair, including abdominal aortic aneurysmand thoracic aneurysms (EVAR and TEVAR), transcatheter aortic valvereplacement (TAVR), patent foramen ovale (PFO) treatment, left atrialappendage occlusion (LAAO), structural heart treatments, atrialfibrillation treatments, and others. The flow devices of the systems areable to be left in the patient for extended periods and retrieved postprocedure.

Some methods of treatment involve the use of multiple, independent,retrievable flow devices acting as embolic protection devices deployedin the arch vessels (e.g., for TEVAR and TAVR) and/or the visceralvessels (e.g., carotid artery, superior mesenteric artery, left andright renal arteries, and inferior mesenteric artery) in conditionswhere the risk of embolic debris is significant, for example. Retrievalpost endovascular and/or surgical procedure is optionally accomplishedutilizing a retrieval system (e.g., a snare retrieval system) such asthose previously described.

FIG. 13 shows a flow device system 900, deployed in a systemic treatmentapproach, according to some examples. FIG. 13 shows the aortic arch 1000and its junctions with the brachiocephalic artery 1002, the left commoncarotid artery 1004, and the left subclavian artery 1006. As shown, aplurality of flow devices 910 similar to the flow device 10 areimplanted in the arteries 1002, 1004, 1006 for systemic protection inassociation with a procedure, such as those previously described fortreating the heart or aorta, for example. In some examples, the flowcontrol portions of the devices 910 are placed near the ostia of thearteries 1002, 1004, 1006 to filter emboli out of the flow in the aorticarch 1000 and deflect emboli downstream, for example.

Any of the devices 10, 110, 210, 310, 410, 510, and combinationsthereof, are contemplated for such applications. For example, althoughin the example of FIG. 13 the devices 910 are similar to device 10, insome examples, one more devices similar to device 510 are placed in oneor more of the arteries 1002, 1004, 1006 with the flow control portion552 oriented toward the vessel ostia. For example, in some examples, theflow control portion 552 includes a fibrous material that extends acrossthe inner-lumen of the support frame 512, having the fibers of the flowcontrol portion 552 oriented as desired relative to blood flow (e.g.,generally perpendicular or oblique to the direction of flow). In otherexamples, the flow control portion 552 includes one or more portionssimilar to other designs previously described.

As discussed above, in some examples, the flow devices may be configuredto be delivered “off-the-wire.” That is, in some examples, the flowdevices are configured to be delivered to a treatment site within apatient's vasculature without riding on a guidewire captured within alumen of the device. However, as mentioned above, in some examples, oneor more guidewires may be utilized during delivery of the flow devicesdisclosed herein.

Turning now to FIG. 14, a flow device 10 (similar to flow device 10discussed above) is configured to be deliverable along a guidewire 66.In some examples, one or more apertures are formed in the device 10 suchthat the device 10 can be translated along a guidewire during deliveryto the target site. The exemplary flow device 10 illustrated in FIG. 14includes a first aperture 54 formed in the capture feature 40 and asecond aperture 56 formed in the capture feature 32.

Those of skill in the art will appreciate that, similar to theoff-the-wire examples discussed herein, such devices may alternativelybe delivered to a treatment site along a guidewire and deployed usingwell known intravascular catheter techniques from a compacted deliveryprofile to an expanded deployed profile. In some examples, upon deliveryand deployment, the guidewire can be subsequently removed from thedevice and such devices can be left in the body following a procedure ora portion of a procedure. That is, in some examples, the guidewire maybe removed such that the device may remain implanted for a desiredperiod (e.g., maintaining a desired patency for a period of between 0.5hours and 7 days) following completion of a procedure (e.g., TEVAR). Asexplained above, such an approach may reduce the incidence ofpostoperative complications (e.g., stroke from embolic debris).

In examples where radiopaque markers are situated or received andretained by the capture features (or capture elements), one or morelumens may be formed through such radiopaque markers such that thedevice 10 can be delivered along the guidewire 66. Those of skill in theart will appreciate that such lumens can be formed in radiopaque markerswithout significantly diminishing the radiopacity of the radiopaquemarker. In some examples, a single lumen may be formed through aradiopaque marker. In some other examples, a number of lumens may beformed through a radiopaque marker. In some examples, forming aplurality of lumens through a radiopaque marker may assist with the easeof loading the device on the guidewire. Thus, in some examples where asingle lumen is formed in a radiopaque marker, it may be beneficial tofix a relative orientation of the radiopaque marker and the capturefeature (or capture element) within which it is received. In some suchexamples, the radiopaque marker may be prevented from rotating orrolling within the capture feature (or capture element).

Although the device 10 illustrated in FIG. 14 is shown with theguidewire 66 extending thorough each of capture features 32 and 40, insome examples, the device may be loaded on the guidewire such that theguidewire extends through a subset or less than all of the capturefeatures (or capture elements) of the device. For example and withreference to the device 10 illustrated in FIG. 14, in some instances,the device 10 may be loaded onto the guidewire 66 such that theguidewire 66 extends through the first capture feature 32 or secondcapture feature 40, but not both. In some such examples, a flow devicemay be loaded on the guidewire such that the flow device extends throughonly a distally located capture feature (or capture element), oralternatively only a proximally located capture feature (or captureelement). Similarly, it should be appreciated that the flow devicesdisclosed herein may be loaded on the guidewire in either of adistal-to-proximal orientation or a proximal-to-distal orientation. Thatis, in some examples, the flow devices may be reversibly loaded on theguidewire.

Those of skill should appreciate that such a configuration providesversatility in that the devices may be deliverable from either anantegrade or retrograde direction. In various examples, the flow devicesdisclosed herein may be loaded on any commercial over the shelfguidewire.

As discussed above, in some examples where the device is delivered overa guidewire, the guidewire may be removed from the device after thedevice is delivered and deployed. In some other examples, upondeployment of the device, the device becomes secured at its positionalong the guidewire. Specifically, in some examples, upon deployment thecapture features (or capture elements) through which the guidewireextends secure the guidewire therein. In some examples, the capturefeatures (or capture elements) include one or more guidewire engagementelements that are configured to interface with the guidewire upondeployment of the device. For example, as shown in FIG. 14 secondcapture feature 40 includes a plurality of guidewire engagement elements58. In some examples, prior to deployment of the device, the guidewireengagement elements are disengaged from the guidewire such that thedevice can be translated along the guidewire. That is, prior todeployment of the device, the guidewire engagement elements do notoperate to secure the device against axial translation the guidewire.However, in these examples, upon deployment of the device, theengagement features engage the guidewire and operate to obstruct orotherwise prevent the device from being further axially translated alongthe guidewire. In some examples, upon retrieval of the device, thedevice is collapsed to its pre-deployment configuration wherein theguidewire engagement elements are disengaged from the guidewire suchthat the device can be translated along the guidewire. In some otherexamples, the guidewire engagement elements remain engaged with theguidewire even after the device is collapsed to its pre-deploymentconfiguration. In some such examples, the guidewire can be utilized todraw the device into a retrieval sheath or allow for a snare to beadvanced over the existing guidewire to capture the device by snaring acapture feature (or capture element) and subsequently drawing the deviceinto a retrieval sheath (such as a guide catheter as discussed herein)as will be appreciated by those of skill in the art.

In some examples, the device is configured such that it is operable tobe delivered in either an off-the-wire configuration or an over-the-wireconfiguration. Specifically, the device may be delivered off-the-wiredespite being adapted or otherwise configured to be loaded onto anddelivered via a guidewire. Indeed, in some examples, a device may beconfigured for delivery over a guidewire yet be delivered off-the-wire.In some examples where the device is configured to be loaded on anddelivered via a guidewire, the lumens extending through the capturefeatures (or capture elements) are generally configured such that debriscaptured by the flow media is not free to escape therethrough. In someexamples, one or more one-way valves (e.g., such as one-way hemostaticvalves) are integrated into the device such that captured debris isobstructed from escaping from the flow media through the lumens. In someexamples, the filter media includes a guidewire lumen that is configuredto accommodate the guidewire passing therethrough. In some examples, thefilter media extends into a guidewire lumen extending through one ormore components or portions of the device (such as the aperture or lumenextending through the capture feature, as explained below), wherein theguidewire lumen is collapsible or blockable (as discussed below).

In some examples, the one-way valve operates to allow a guidewire topass through the device (such as through one or more of the lumens ofthe capture features or other lumens of the device). In some examples,one or more one-way valves are positioned adjacent the filter media. Insome such examples, the one or more one-way valves are positioned in orproximate to the lumens of the capture features (or capture elements).In some examples, a one-way valve is incorporated into the capturefeature or the lumen thereof. In some examples, the capture featureitself operates as a one-way valve. In some such examples, the one ormore guidewire engagement elements of the capture feature (or captureelement) may be multipurposed in that they operate to secure the capturefeature (and thus the device) to the guidewire (as explained above) andadditionally operate together to obstruct debris from escaping throughthe aperture formed therein when the guidewire is not otherwiseextending therethrough.

In some examples, in addition to blocking debris from escaping from thefilter media, one or more of the one or more one-way valves engage theguidewire such that the device is obstructed from translating along thewire (as discussed above). Thus, in some examples, a one-way valve maybe multipurposed to block the escape of debris (such as embolic debris)as well as secure the device to the guidewire.

In some examples, one-way valves may be incorporated distally,proximally, or both distally and proximally of the filter media (alsodescribed as ante- or retrograde in terms of flow). Thus, it will beappreciated that the device may include a single one-way valve, ormultiple one-way valves. In some examples where a single one-way valveis incorporated into the device, the single one-way valve may bepositioned relative to the filter media such that the one-way valve isfurther antegrade (or downstream relative to the heart).

In some examples, one or more tension springs or other resilient membersoperate to secure the device to the guidewire. In some examples, thecapture feature (or capture element) includes one or more tensionsprings that operate to cause the capture feature to engage the wiresuch that the device is obstructed from translating along the wire (asdiscussed above). In some examples, the one or more tension springsadditionally or alternatively operate to constrict, collapse, orotherwise block the lumen or aperture extending through the capturefeatures (or capture elements) when the guidewire is removed therefrom.In some examples, as mentioned above, the filter media extends into suchlumens, and when the resilient member(s) cause the lumen to collapse,the debris remains captured by the filter media.

Additionally, in some examples, one or more elastic membranes, siliconegrommets, and/or flapper valves may be utilized to prevent debris fromescaping from the filter media through a guidewire lumen therein (asmentioned above). In some examples, such components operate to closewith impinging flow

Although various examples of applications of the devices describedherein and associated systems have been described it should be apparentthat any of applications are contemplated. Various modifications andadditions can be made to the exemplary examples discussed withoutdeparting from the scope of the present disclosure. For example, whilethe examples described above refer to particular features, the inventivescope of this disclosure also includes examples having differentcombinations of features and examples that do not include all of theabove described features.

The following is claimed:
 1. A medical device comprising: a supportstructure that is collapsible, includes a plurality of struts, and has aproximal end, a distal end, and an intermediate portion locatedtherebetween; a flow media attached to an inside of the supportstructure and comprising a portion configured to flexibly and reversiblyextend from the intermediate portion toward the proximal end or thedistal end of the support structure while hinging on the intermediateportion according to flow direction; and a proximal capture featurecoupled to the proximal end of the support structure and a distalcapture feature coupled to the distal end of the support structure, theproximal and distal capture features facilitating deployment of themedical device and capture of the medical device, wherein at least oneof the proximal and distal capture features is substantially spherical.2. The medical device of claim 1, further comprising a snare catheterwith a loop, the proximal capture feature captured by the loop.
 3. Themedical device of claim 1, wherein the flow media is configured tofilter fluid flowing through a vessel.
 4. The medical device of claim 3,wherein the flow media includes a first side and a second side and isattached to the support structure such that either the first side or thesecond side of the flow media is adapted to filter fluid flowing throughthe flow media.
 5. The medical device of claim 3, wherein the flow mediaincludes pores having an average size ranging between 100 and 500micrometers and a patency in the range of between 12 hours and 7 days.6. The medical device of claim 1, wherein the flow media is configuredto occlude fluid flowing through a vessel.
 7. The medical device ofclaim 6, wherein the flow media includes pores having an average size ofless than 100 micrometers and a patency configured to provide a gradualocclusion of a vessel.
 8. The medical device of claim 1, wherein theflow media is formed from a polymeric material.
 9. The medical device ofclaim 1, wherein the support structure includes an inner lumen and theflow media comprises a porous fabric and is attached to the supportstructure such that it extends across the inner lumen.
 10. The medicaldevice of claim 1, wherein the support structure is formed from a cuttube.
 11. The medical device of claim 1, the distal capture featurecomprising an aperture allowing the distal capture feature to bearranged over a guidewire.
 12. The medical device of claim 1, whereinthe plurality of struts and the at least one of the proximal and distalcapture features are integrally formed portions of a single tubularmember.
 13. The medical device of claim 1, wherein at least one of theproximal end or the distal end defines a conical portion of the supportstructure that tapers longitudinally away from the intermediate portion.14. The medical device of claim 13, wherein the flow media extends fromthe intermediate portion toward the conical portion such that the flowmedia is supported within the conical portion of the support structure.15. A medical system comprising: a medical device including: a supportstructure including a plurality of struts, having a first end, a secondend, and an intermediate portion located therebetween; a flow mediaattached to an inside of the support structure and comprises a portionconfigured to flexibly and reversibly extend from the intermediateportion toward the first end or the second end of the support structurewhile hinging on the intermediate portion according to flow direction;and a proximal capture feature and a distal capture feature, theproximal and distal capture features facilitating deployment of themedical device and capture of the medical device, and at least one ofthe proximal and distal capture features being substantially spherical;a catheter configured to receive the medical device therein; and a snareconfigured to engage either of the proximal capture feature and thedistal capture feature such that the medical device is retrievable fromboth an antegrade direction and a retrograde direction.
 16. The medicalsystem of claim 15, further comprising a guidewire, the medical devicereceived on the guidewire.
 17. The medical system of claim 16, whereinthe guidewire extends through at least one of the proximal and distalcapture features.
 18. The medical system of claim 16, wherein at leastone of the proximal and distal capture features is configured toreleasably engage the guidewire such that the medical device can betranslated along the guidewire prior to deployment of the medical deviceand such that the medical device is constrained against translationalong the guidewire upon deployment of the medical device.
 19. Themedical system of claim 15, the proximal capture feature comprising alumen allowing the proximal capture feature to be arranged over aguidewire.
 20. A medical device comprising: a support structure that iscollapsible, includes a plurality of struts, has a proximal end, adistal end, and an intermediate portion located therebetween; a flowmedia attached to an inside of the support structure and comprises aportion configured to flexibly reverse direction between extendingtoward the proximal end or the distal end of the support structureaccording to a change in flow direction; and a distal capture feature atthe distal end of the support structure, the distal capture featurefacilitating antegrade deployment of the medical device and antegradecapture of the medical device, and the distal capture feature beingsubstantially spherical.
 21. A medical device comprising: a supportstructure that is collapsible, includes a plurality of struts, and has afirst end, a second end, and an intermediate portion locatedtherebetween; a flow media attached to the support structure, the flowmedia being conical or dome-shaped and configured to reversibly extendfrom the intermediate portion toward the first end or the second end ofthe support structure while within a body lumen; a first capture featureat the first end of the support structure and a second capture featureat the second end of the support structure, the first and second capturefeatures facilitating deployment of the medical device and recapture ofthe medical device following deployment, wherein the first capturefeature defines an interior space; and a radiopaque marker enclosedwithin the interior space of the first capture feature.
 22. A medicalsystem comprising: a medical device including: a support structureincluding a plurality of struts, having a first end, a second end, andan intermediate portion located therebetween; a flow media attached tothe support structure, the flow media being conical or dome-shaped andconfigured to reversibly extend from the intermediate portion toward thefirst end or the second end of the support structure while within a bodylumen; and a first capture feature and a second capture feature, thefirst and second capture features facilitating deployment of the medicaldevice and recapture of the medical device following deployment, and aradiopaque marker enclosed within the first capture feature; a catheterconfigured to receive the medical device therein; and a snare configuredto engage the first capture feature and the second capture feature suchthat the medical device is retrievable from both an antegrade directionand a retrograde direction.
 23. A medical device comprising: a supportstructure that is collapsible, includes a plurality of struts, and has aproximal end, a distal end, and an intermediate portion locatedtherebetween, wherein at least one of the proximal end or the distal enddefines a conical portion of the support structure that taperslongitudinally away from the intermediate portion; and a flow mediaattached to and configured to reversibly hinge on the intermediateportion of the support structure, wherein the flow media extends fromthe intermediate portion and is configured to be positioned toward theconical portion such that the flow media is supported within the conicalportion of the support structure or positioned away from the conicalportion as dictated by flow direction.
 24. A medical device comprising:a support structure that is collapsible, includes a plurality of struts,and has a proximal end, a distal end, and an intermediate portionlocated therebetween, wherein at least one of the proximal end or thedistal end defines a conical portion of the support structure thattapers longitudinally away from the intermediate portion; and a flowmedia attached to the support structure, wherein the flow media extendsfrom the intermediate portion and is configured to be reversiblypositioned toward the conical portion such that the flow media issupported within the conical portion of the support structure orpositioned away from the conical portion as dictated by a change in flowdirection.
 25. A medical device comprising: a support structure that iscollapsible, includes a plurality of struts, and has a proximal end, adistal end, and an intermediate portion located therebetween, wherein atleast one of the proximal end or the distal end defines a conicalportion of the support structure that tapers longitudinally away fromthe intermediate portion; and a flow media attached to the supportstructure, wherein the flow media extends from the intermediate portionand is configured to be reversibly positioned toward the conical portionsuch that the flow media is supported within the conical portion of thesupport structure or positioned away from the conical portion asdictated by flow direction while within a body lumen.